Quality Assurance & Improvement Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Assurance & Improvement flashcards as text
Which audit methodology involves evaluating a research site's processes BEFORE a significant regulatory inspection to identify gaps?
Answer: Mock inspection
A mock inspection simulates a regulatory authority visit to proactively identify and correct deficiencies before the real inspection.
A CAPA plan for a protocol deviation should PRIMARILY focus on:
Answer: Preventing recurrence through systemic process changes
Effective CAPA addresses root causes through systemic improvements to prevent the same deviation from recurring.
When a quality indicator trend shows increasing protocol deviation rates over three consecutive months, the FIRST appropriate step is to:
Answer: Conduct a root cause analysis
Root cause analysis must precede any corrective action to ensure interventions target the actual source of the problem.
Which document type provides the sponsor's detailed expectations for site monitoring visit frequency and procedures?
Answer: Monitoring Plan
The Monitoring Plan outlines the sponsor's risk-based strategy for oversight including visit frequency, scope, and required documentation reviews.
Risk-Based Quality Management (RBQM) differs from traditional monitoring primarily by:
Answer: Focusing oversight resources on the highest-risk data and processes
RBQM concentrates monitoring efforts where risks to subject safety and data integrity are greatest rather than applying uniform oversight to all activities.
A key performance indicator (KPI) used to measure data entry quality at a clinical site is:
Answer: Query rate per 100 data fields entered
Query rate measures how often entered data requires clarification, directly reflecting the accuracy and completeness of data entry practices.
Under 21 CFR Part 11, electronic records used in clinical research must include which quality control feature?
Answer: Audit trail capturing who made changes and when
21 CFR Part 11 requires a secure, computer-generated audit trail that records the date and time of operator entries and actions that create, modify, or delete electronic records.